CorMedix Inc. CRMD announced it has received a Special Protocol – Agreement letter from the U.S. Food and Drug Administration regarding a Special Protocol Assessment on the design of a pivotal Phase 3 trial for the Company's oral formulation of CRMD001 in the prevention of Contrast-Induced Acute Kidney Injury.
This SPA takes into consideration a modification to the dosing regimen contained in the previously submitted protocol.
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